Portable dual-energy radiographic x-ray perihpheral bone density and imaging systems and methods

ABSTRACT

Devices, tools, systems and methods for X-ray bone density measurement and imaging for radiography, fluoroscopy and related procedures. Portable, efficient peripheral bone density measurement and/or high resolution imaging and/or small field digital radiography of bone and other tissue, including tissue in the peripheral skeletal system, such as the arm, forearm, leg, hand and/or foot.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. ProvisionalApplication No. 61/664,066, filed on Jun. 25, 2012, which isincorporated in its entirety by reference herein. Any and all priorityclaims identified in the Application Data Sheet, or any correctionthereto, are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND

1. Field

Embodiments of the present invention generally relate to devices, tools,systems and methods for X-ray bone density measurement and imaging forradiography, fluoroscopy and related procedures. More specifically,embodiments of the present invention relate to devices, tools, systemsand methods for portable, efficient peripheral bone density measurementand/or high resolution imaging and/or small field digital radiographyand/or fluoroscopy of bone and other tissue, including tissue in theperipheral skeletal system, such as arms, legs, hands and feet. In oneembodiment, a system uses single energy. In one embodiment, a systemuses dual energy.

2. Description of the Related Art

Osteoporosis is a systemic skeletal disease characterized by low bonedensity and microarchitectural deterioration of bone tissue with aconsequential increase in bone fragility. Osteoporosis affects anestimated 75 million people in Europe, the United States and Japan. Theestimated cost of osteoporotic fracture care exceeds $13-18 billionannually in the United States alone. Diagnosis of osteoporosis iscurrently generally performed by measurement of bass mass loss or BoneMineral Density (“BMD”).

Presently, three major types of bone densitometers are commerciallyavailable: Dual-Energy X-ray Absorptiometry (“DXA”), QuantitativeUltrasound (“QUS”) and Quantitative Computed Tomography (“QCT”). DXA isoften regarded as a gold standard for BMD and bone loss assessment, duein part to its high precision and low radiation dose. However, thecurrent standard tests performed by whole-body DXA scanner systems areexpensive with limited availability in large hospitals and medicalimaging centers in cities. Further, most DXA systems are very large toaccount for the power requirements in conducting full body scanning.Many commonly used bone densitometers in the United States, Europe andCanada are whole-body DXA scanners. In general, current conventional DXAtechnology uses a fan beam geometry with imaging quality that isrelatively poor. There is need for low-cost, portable, wireless capablediagnostic imaging devices that can be used at the point-of-patient carefor disadvantaged and under-served populations, including those inremote or rural communities and small hospitals throughout the world.

SUMMARY

Further areas of applicability will become apparent from the descriptionprovided herein. It should be understood that the description andspecific examples are intended for purposes of illustration only and arenot intended to limit the scope of the embodiments disclosed herein.

In one embodiment, a portable, dual-energy radiographic x-ray imagingand bone density measuring system includes an X-ray tube, an X-rayimaging detector, a housing, and an embedded system. The X-ray tube isconfigured to emit an X-ray beam through a filter positioning mechanism.The filter positioning mechanism includes a high energy filter, a lowenergy filter, and a shutter configured to block transmission of theX-ray beam. The housing positions the X-ray tube at a distance from theX-ray beam detector, wherein the housing is configured for positioning aforearm between the X-ray tube and the X-ray beam detector. The embeddedsystem is configured to activate the X-ray tube and to control theposition of the filter positioning mechanism and imaging dataacquisition. In one embodiment, the embedded system is an operatingsystem. In one embodiment, the embedded system manages powerrequirements, processes data, controls LCD/touchscreen and all systemcommunications that includes USB and wireless communications.

In one embodiment, the X-ray tube is active for at most two seconds perexposure. In one embodiment, the high energy filter provides a highenergy component for transmission through the filter positioningmechanism, and limits low energy transmission. In one embodiment, thehigh energy filter absorbs lower energy. In one embodiment, the highenergy filter provides a high energy component of 40-50 kV or more fortransmission through the filter positioning mechanism. In oneembodiment, the high energy filter comprises copper and at least one ofthe group consisting of tin and rhodium. In one embodiment, the lowenergy filter provides for lower energy transmission of energy throughthe filter positioning mechanism. In one embodiment, the low energyfilter provides for lower energy transmission of energy below 40-50 kVthrough the filter positioning mechanism. In one embodiment, the lowenergy filter comprises aluminum and at least one type of materialhaving a K-edge absorption of 40 kV or more. In one embodiment, amaterial having a K-edge absorption of 40 kV or more is selected fromthe group consisting of cerium, samarium, gadolinium, and barium.

In one embodiment, the filter positioning mechanism is actuated by astepper motor in electric communication with the embedded system. In oneembodiment, the filter positioning mechanism is a filter exchangerconfigured to be rotatably or linearly actuated by a stepper motor. Inone embodiment, the stepper motor is a high torque and high speed designthat enables to switch one position to another in 100 ms or less. In oneembodiment, the embedded system provides high-speed/high bandwidth datatransmission configured for transmission of imaging data in less than100 ms. In one embodiment, the X-ray imaging detector transmits imagedata through any one of the group consisting of a Gig-Ethernet and acamera link. In one embodiment, the embedded chip system operates theX-ray tube at a duty cycle of approximately 1/60, for a one secondactive pulsed radiation to sixty second inactive period. In oneembodiment, the embedded chip system operates the X-ray tube at a dutycycle for a two second active pulsed radiation to one hundred twentysecond inactive period. In one embodiment, the embedded can include anoperating system configured to process data, control a LCD/touchscreen,manage a power supply, and/or control a communication with any of awired communication, a USB communication and/or a wirelesscommunication. In one embodiment, the system is configured as a batterypowered device.

In one embodiment, a method for measuring peripheral bone densityincludes positioning a forearm of a patient between an X-ray source anda beam detector in an X-ray system. The X-ray tube is configured to emitan X-ray beam through a filter positioning mechanism. The filterpositioning mechanism includes a high energy filter, a low energyfilter, and a shutter configured to block transmission of the X-raybeam. The method includes activating an embedded chip in the X-raysystem, with the embedded chip configured to activate the X-ray tube andto control the position of the filter positioning mechanism. In oneembodiment, the activating the embedded chip includes activating theX-ray tube for two seconds or less, moving the filter positioningmechanism from a shuttered position to a low energy position with saidhigh energy filter, acquiring low energy data, moving the filterpositioning mechanism from the low energy position to a high energyposition with said low energy filter, and acquiring high energy data.

In one embodiment, a method for measuring peripheral bone densityincludes positioning a forearm of a patient between an X-ray source anda beam detector in an X-ray system. The X-ray tube is configured to emitan X-ray beam through a filter positioning mechanism, the filterpositioning mechanism comprising a first energy filter, a second energyfilter, and a shutter configured to block transmission of the X-raybeam. In one embodiment, a step includes activating an embedded chip insaid X-ray system, the embedded chip configured to activate the X-raytube and to control the position of the filter positioning mechanism. Inone embodiment, a step includes activating the X-ray tube for twoseconds or less. In one embodiment, a step includes moving the filterpositioning mechanism from a shuttered position to a first energyposition with said first energy filter. In one embodiment, a stepincludes acquiring first energy data. In one embodiment, a step includesmoving the filter positioning mechanism from the first energy positionto a second energy position with said second energy filter. In oneembodiment, a step includes acquiring second energy data.

In one embodiment, a portable, single-energy radiographic x-ray systemincludes an X-ray monoblock configured to emit an X-ray beam through afilter positioning mechanism, the filter positioning mechanism includinga high energy filter, a low energy filter, and a shutter configured toblock transmission of the X-ray beam. In one embodiment, the systemincludes an X-ray imaging detector. In one embodiment, the systemincludes an anti-scattering grid between the X-ray monoblock and theX-ray imaging detector. In one embodiment, the system includes a housingpositioning the X-ray source at a distance from the X-ray beam detector,wherein the housing is configured for positioning a portion of a bodybetween the X-ray source and the X-ray beam detector. In one embodiment,the system includes an embedded system configured to activate the X-raysource and to control the position of the filter positioning mechanismand imaging data acquisition. In one embodiment, the system isconfigured for single exposure. In one embodiment, the system isconfigured for continued pulse exposure. In one embodiment, the systemis configured as a battery powered device.

In various embodiments, any combination of features from any embodimentsmay be substituted, combined, or varied.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings described herein are for illustration purposes only and arenot intended to limit the scope of the present disclosure in any way.Embodiments of the present invention will become more fully understoodfrom the detailed description and the accompanying drawings wherein:

FIG. 1 is a block schematic diagram view of an X-ray system according toan embodiment of the present invention;

FIG. 2 is a block schematic diagram view of an X-ray system according toan embodiment of the present invention;

FIG. 3 is a block schematic diagram view of an X-ray system according toan embodiment of the present invention;

FIG. 4A is a schematic time table of various actions performed in a timeperiod by an X-ray system with a constant high voltage (HV) X-Ray tubeaccording to an embodiment of the present invention;

FIG. 4B is a schematic time table of various actions performed in a timeperiod by an X-ray system with a switchable X-ray tube HV without afilter exchanger according to an embodiment of the present invention;

FIG. 4C is a schematic time table of various actions performed in a timeperiod by an X-ray system with a combination of switchable HV with afilter exchanger according to an embodiment of the present invention;

FIG. 4D is a schematic time table of various actions performed in a timeperiod by an X-ray system with a single-energy radiographic operationaccording to an embodiment of the present invention;

FIG. 4E is a schematic time table of various actions performed in a timeperiod by an X-ray system with a single-energy, continued pulse exposureoperation according to an embodiment of the present invention;

FIG. 4F is a flow chart of various steps performed by an X-ray systemaccording to an embodiment of the present invention;

FIG. 5A is a schematic top view of a filter positioning mechanismaccording to an embodiment of the present invention;

FIG. 5B is a schematic side view of the filter positioning mechanismaccording to FIG. 5A;

FIG. 6 is an isometric view of the filter positioning mechanism with anX-ray tube according to FIG. 5A;

FIG. 7 is an isometric front and back view of an X-ray system accordingto an embodiment of the present invention;

FIG. 8A is a radiographic image of a forearm by an X-ray systemaccording to an embodiment of the present invention;

FIG. 8B is a bone density image of the forearm by the X-ray systemaccording to FIG. 8A;

FIG. 9A is an isometric front view of an X-ray system according to anembodiment of the present invention;

FIG. 9B is a side view of the X-Ray system according to FIG. 9A;

FIG. 9C is an isometric back view of the X-Ray system according to FIG.9A;

FIG. 10 is an isometric front view of the housing of the X-Ray systemaccording to FIG. 9A;

FIG. 11 is an isometric front view of the X-Ray system according to FIG.9A;

FIG. 12 is an isometric view of the X-Ray system according to FIG. 9A;

FIG. 13 is an isometric rear view of the X-Ray system according to FIG.9A.

DETAILED DESCRIPTION

The following description sets forth examples of embodiments, and is notintended to limit the present invention or its teachings, applications,or uses thereof. It should be understood that throughout the drawings,corresponding reference numerals indicate like or corresponding partsand features. The description of specific examples indicated in variousembodiments of the present invention are intended for purposes ofillustration only and are not intended to limit the scope of theinvention disclosed herein. Moreover, recitation of multiple embodimentshaving stated features is not intended to exclude other embodimentshaving additional features or other embodiments incorporating differentcombinations of the stated features. Further, features in one embodiment(such as in one figure) may be combined with descriptions (and figures)of other embodiments.

In various embodiments, an X-ray system 100 can be configured forvarious uses, improvements, and/or advantages over existing systems. Forexample, conventional technology for assessing fracture risk throughmeasurement of bone density or bone mineral density (BMD) tends to belarge, bulky, complex, and/or costly for many people at risk of bonefractures. Other conventional lower cost diagnostic systems may beinaccurate or lack sufficient resolution for diagnosing bone fractureand/or density risk. Difficulty in accessing conventional diagnosticsystems may lead to under identification of bone fracture risk, whichcan cause significant increases in overall healthcare costs.

In various embodiments of the present invention, an X-ray system 100 isconfigured to assess and/or diagnose bone fracture risk through theassessment of bone mineral density, bone structure, or both. In oneembodiment, an X-ray system 100 is configured with enhanced spatialresolution. In one embodiment, an X-ray system 100 is configured withenhanced temporal resolution. In one embodiment, an X-ray system 100 isconfigured with enhanced specificity. In one embodiment, an X-ray system100 is configured for BMD measurement. In one embodiment, an X-raysystem 100 is configured to perform bone geometric analysis. In oneembodiment, an X-ray system 100 is configured to perform bone strengthanalysis. In various embodiments, any number of X-ray system 100embodiments can be combined or arranged with any embodiments,components, functions, and/or capabilities.

In one embodiment, an X-ray system 100 is a radiography and/or imagingsystem. In one embodiment, an X-ray system 100 is a bone densitymeasuring system. In one embodiment, an X-ray system 100 is aradiography imaging system and a bone density measuring system. In oneembodiment, an X-ray system 100 is a combination of any of theembodiments or components, functions, and/or capabilities. In oneembodiment, an X-ray system 100 is a dual-function system. In oneembodiment, an X-ray system 100 is a digital radiography system. In oneembodiment, an X-ray system 100 is a dual energy X-ray absorptiometry(DXA) system. In one embodiment, an X-ray system 100 is configured foruse on the peripheral skeletal system. In one embodiment, an X-raysystem 100 is a mobile forearm digital radiography and dual-energy X-rayabsorptiometry system. In one embodiment, an X-ray system 100 isconfigured as a battery powered device.

In some embodiments, an X-ray system 100 is configured for one or morefunctions. In one embodiment, an X-ray system 100 is configured forsmall field radiography. In one embodiment, an X-ray system 100 isconfigured for imaging and/or bone density measurements of the arm,forearm, hand, finger, wrist, leg, ankle, heal, foot, and/or toe. In oneembodiment, an X-ray system 100 is configured for superior imaging foranalyzing bone structure/strength (such as bone geometry, cortical bonethickness, etc.). In one embodiment, an X-ray system 100 is configuredto use both diagnostic and density images for bone age assessment. Inone embodiment, an X-ray system 100 is configured for forearm bonedensity screening. In one embodiment, an X-ray system 100 is configuredfor testing of ultra-distal (“UD”) radius and/or at the 33% radius for adominate arm, a non-dominate arm, or both. Because the ultradistalradius region of interest (UDR) has a greater ratio of trabecular tocortical bone than midshaft portions of the radius, it is possible thatmore patients would be classified as osteoporotic if the UDR ismeasured. In 2004, the ISCD (Internal Society of Clinic Densitometry)published its official position recommending the 33% radius as a regionof interest. In one embodiment, an X-ray system 100 is configured forsmall animal research. In one embodiment, an X-ray system 100 isconfigured for laboratory research.

BMD can be measured in terms of T-scores categories from the WorldHealth Organization (“WHO”), which is generally based on bone density inwhite women. For example, in white adult women, a normal bone T-score isgreater than −1. Osteopenia corresponds to a T-score between −1 and−2.5. Osteoporosis has a T-score less than −2.5. Severe (established)osteoporosis T-scores are less than −2.5. In making adjustments tocategorizations of BMD measurement in other ethnic groups, men, andchildren, there are a number of considerations that certain embodimentsof the present invention can address.

Generally, comparing the bone mineral density of children to thereference data of adults (to calculate a T-score) will underestimate theBMD of children, because children have less bone mass than fullydeveloped adults. The WHO classification of osteoporosis and osteopeniain adults cannot be applied to children. This would lead to anover-diagnosis of osteopenia for children. To avoid an overestimation ofbone mineral deficits, BMD scores are commonly compared to referencedata for the same gender, ethnicity and age, such as through Z-scoremeasurements. Also, there are other variables in addition to age thatare suggested to confound the interpretation of BMD as measured by DXA.One important confounding variable is bone size. DXA has been shown tooverestimate the bone mineral density of taller subjects andunderestimate the bone mineral density of smaller subjects. This erroris due to the way by which general DXA calculates BMD. In DXA, bonemineral content (measured as the attenuation of the X-ray by the bonesbeing scanned) is divided by the area (also measured by the machine) ofthe site being scanned. Because general or standard DXA calculates BMDusing area (aBMD: areal Bone Mineral Density), it is not an accuratemeasurement of true bone mineral density, which is mass divided by avolume. In order to distinguish DXA BMD from volumetric bone-mineraldensity, researchers sometimes refer to DXA BMD as an areal bone mineraldensity (aBMD). The confounding effect of differences in bone size isdue to the missing depth value in the calculation of bone mineraldensity. Methods to correct for this shortcoming include the calculationof a volume that is approximated from the projected area measure by DXA.DXA BMD results adjusted in this manner are referred to as the bonemineral apparent density (BMAD) and are a ratio of the bone mineralcontent versus a cuboidal estimation of the volume of bone. Like theresults for aBMD, BMAD results do not accurately represent true bonemineral density, since they use approximations of the bone's volume.BMAD is used primarily for research purposes and is not yet used inclinical settings. Some clinics may routinely carry out DXA scans onchildren with conditions such as nutritional rickets, lupus, and TurnerSyndrome. DXA has been demonstrated to measure skeletal maturity andbody fat composition and has been used to evaluate the effects ofpharmaceutical therapy. It may also aid health professionals indiagnosing and monitoring treatment of disorders of bone massacquisition in childhood.

In one embodiment, an X-ray system 100 is configured for use with anaging population. In one embodiment, an X-ray system 100 is configuredfor use in diagnosing osteoporosis. In one embodiment, an X-ray system100 is configured for use in pediatrics. In one embodiment, an X-raysystem 100 is configured for diagnosis or assessment of bone age growthin children. In one embodiment, an X-ray system 100 is configured toidentify growth disorders. In one embodiment, an X-ray system 100 isconfigured for predicting adult height. In one embodiment, an X-raysystem 100 is used in conjunction with drug treatment and/or therapy tomonitor progress and/or effectiveness of a drug or therapy. In oneembodiment, an X-ray system 100 is configured for small fieldradiography. In one embodiment, an X-ray system 100 is configured forsmall animal research. In some embodiments, an X-ray system 100 can be alow cost device (for example, in comparison to total body DXA scanner orQCT systems).

FIGS. 1-3 illustrate various schematic embodiments of an X-ray system100 with various components 110 (not shown in the drawing). Anycomponent 110 can be used in any embodiment with or without any othercomponent 110. In one embodiment, an X-ray system 100 is configured forlow cost manufacturing. In one embodiment, an X-ray system 100 isconfigured for low cost service. In one embodiment, an X-ray system 100is configured for Design For Manufacturability (DFM) that enhancessystem integration. In one embodiment, an X-ray system 100 is configuredfor DFM with any component 110. In various embodiments, variouscomponents 110 include any device, module, interface, system, connector,or other unit. In one embodiment, X-ray imaging data is acquired fromflat-panel imaging detector through Gig Ethernet. In one embodiment,X-ray imaging data is acquired from flat-panel imaging detector throughCamera Link.

In various embodiments, an X-ray system 100 comprises a housing 120. Inone embodiment, the housing 120 is an enclosure built to contain othercomponents of the X-ray system 100. In one embodiment, an X-ray system100 comprises an improved form factor. In one embodiment, an X-raysystem 100 is a portable system. In one embodiment, an X-ray system 100is a mobile system. In one embodiment, a portable X-ray system 100 isconfigured with a housing 120 for greater mobility based on a relativelysmall form factor and light weight. In one embodiment, an X-ray system100 can be hand carried. In some embodiments, an X-ray system 100 can be40 pounds or lighter. In some embodiments, an X-ray system 100 can be 30pounds or lighter. In some embodiments, an X-ray system 100 can be 25pounds or lighter. In some embodiments, an X-ray system 100 can be 20pounds or lighter. In some embodiments, an X-ray system 100 can be 15pounds or lighter. In some embodiments, an X-ray system 100 can be 10pounds or lighter. In some embodiments, an X-ray system 100 can be 5pounds or lighter. In some embodiments, an X-ray system 100 can have amaximum weight of any weight in the range of 0-50 pounds, 10-40 pounds,10-30 pounds, 10-20 pounds, 10-15 pounds, 15-20 pounds, or any otheramount or range therein. In one embodiment, an X-ray system 100 isbetween 10-15 pounds. In one embodiment, an X-ray system 100 is between10-20 pounds. In some embodiments, an X-ray system 100 can be handcarried. In some embodiments, an X-ray system 100 can fit into any roomin any setting, such as a clinic, doctor office, medical professionalunit, tent, mobile unit, triage center, or other locations. In someembodiments, an X-ray system 100 has various dimensions for improvedportability, such as a length, width and/or height of approximately 100cm, 90 cm, 80 cm, 70 cm, 60 cm, 50 cm, 40 cm, 30 cm, 20 cm, 10 cm orless, or of any range therein. In one embodiment, an X-ray system 100 isconfigured to have a physical size dimension of approximately 35 cm inlength, 35 cm in width, and 50 cm in height. In some embodiments, anX-ray system 100 has various dimensions for improved portability, suchas a length, width and/or height of approximately 30, 25, 20, 15, 10, 5inches or less, or of any range therein. In one embodiment, an X-raysystem 100 is configured to have a physical size dimension ofapproximately 14 by 9 inches for a footprint.

In some embodiments, an X-ray system 100 comprises components 110 thatcan communicate and/or be attached to one or more other components 110.In one embodiment, components 110 are connected within the housing 120.In one embodiment, components 110 are connected outside the housing 120.In one embodiment, components 110 are connected within and outside thehousing 120. In one embodiment, an X-ray system 100 is configured forimproved connectivity. In some embodiments, an X-ray system 100comprises a hard-wired connection to other external electronicequipment. In some embodiments, an X-ray system 100 comprises a wirelessconnection to other external electronic equipment. In some embodiments,an X-ray system 100 comprises a connector 130. In various embodiments, aconnector 130 can be any one (or more) of a USB connection 132, awireless connection 134, a Blue-tooth/Wi-Fi connection 136, and/oranother connection. In some embodiments, an X-ray system 100 is selfcontained and does not need a connector 130, cable/wire, extra interfaceor an external computer or personal computer to operate it. In variousembodiments, an X-ray system 100 comprises an interface 140. In oneembodiment, the interface 140 is one or more keys, buttons, keyboards,switches, or other communication interfaces. In one embodiment, theinterface 140 is a touch screen. In one embodiment, the interface 140 isa display. In one embodiment, the interface 140 is a liquid crystaldisplay (LCD). In one embodiment, the interface 140 is LCD touch screen.In various embodiments, the interface 140 can display an image, data,information, and/or status from the X-ray system 100. In variousembodiments, the interface 140 can be used to input data, information,instructions, or other in to the X-ray system 100.

In one embodiment, an X-ray system 100 comprises an embedded system 150.In various embodiments, an embedded system can comprise a chip, CPU,and/or a System-on-chip (SoC) that can include a microprocessor, otherintegrated circuits (ICs), and/or any electronic control system. In oneembodiment, an embedded system is an operating system. In oneembodiment, an embedded system manages power requirements, processesdata, controls LCD/touchscreen and all system communications, includingUSB and/or wireless communications. In one embodiment, an X-ray system100 comprises an embedded system 150 powered by a System-on-Chip (SoC).In one embodiment, an X-ray system 100 comprises an embedded system 150powered by a custom designed printed-circuitry-board(PCB)/System-on-Board (SoB 152). In one embodiment, an X-ray system 100comprises an embedded system 150 powered by SoC and SoB 152. In oneembodiment, an X-ray system 100 comprises an embedded system 150configured for enhanced system performance, especially forhigh-speed/high-bandwidth inter-connectivity and data management. In oneembodiment, an X-Ray control board 151 is used to control an X-Ray tube.In one embodiment, an X-ray system 100 is configured for reducedmaterial cost, resulting in a reduced BOM (Bill of Material) cost. Inone embodiment, an X-ray system 100 uses relatively fewer components 110and materials than other conventional systems. In one embodiment, a SoB152 can have several chip (or ICs) and special circuit designs in orderto control and manage a number of peripheral devices (such as aLCD/touch screen, motor, X-ray power supply, etc.). In one embodiment, aSoB 152 integrates multiple functions into one single piece of board. Invarious embodiments, X-ray and stepper motor controllers control X-rayand motor actions. In various embodiments, power management module canprovide power requirements to any or all peripheral devices. SoB 152 haswire, wireless and display/touchscreen interfaces. In variousembodiments, the SoB 152 includes a Gig-Ethernet, a Camera Link, and/orDDR3 memory designs for high-speed/high-bandwidth data transmission andstorage.

In one embodiment, an X-ray system 100 obtains power from a power source160. In various embodiments, the power source is AC, DC, AC/DC, abattery, or other power source. In one embodiment, an X-ray system 100is configured for AC power. In one embodiment, an X-ray system 100 isconfigured for DC power. In one embodiment, an X-ray system 100 isconfigured to be convertible to a battery powered device. In oneembodiment, an X-ray system 100 is configured to be a battery powereddevice.

In one embodiment, an X-ray system 100 comprises an X-ray tube 200. Inone embodiment, the X-ray source is an X-ray monoblock containing anX-ray tube and an X-ray HV board 200 potted inside. In variousembodiments, any X-ray source can be an X-ray monoblock. X-rays aregenerally produced when an electron beam is accelerated by high voltage(usually in a range from about 40 to 150 kV) then is suddenlydecelerated as it hits a metal target (such as Tungsten, Molybdenum orRhenium) in a vacuum tube. In one embodiment, the X-ray tube 200 issubmerged in high-density insulation oil or some other medium containedin the metal housing. Some metal housings are made of aluminum, steel orlead. This typical reaction results in about 1% of kinetic energy beingconverted into X-ray radiation, with the remaining roughly 99% of thekinetic energy becoming heat that needs to be dissipated to avoidoverheat or damage to the system. In some embodiments, the X-ray tube200 is cooled. Cooling is generally provided by the insulation oil andcan be circulated by pump through air or water or other media forcooling. In one embodiment, the X-ray HV supply is potted inside amonoblock to avoid potential hazards of high voltage exposure to humansand/or the external environment. In general, many medical X-ray devicesoperate at a continuous duty cycle. As a result, most medical X-raydevices are heavy and too bulky to be portable.

One way to reduce the potential of overheating in generating X-rayradiation is to shorten X-ray radiation exposure by changing the dutycycle 210 to allow self-cooling. Thus, in one embodiment, an X-raysystem 100 can operate under a reduced duty cycle 210 instead ofcontinuously generating heat with a continuous duty cycle. In oneembodiment, an X-ray system 100 needs less than 1 second for a singleexposure. In one embodiment, an X-ray system 100 needs less than 2seconds for a single exposure. In one embodiment, an X-ray system 100needs less than 3 seconds for a single exposure. In some embodiments, anX-ray system 100 is configured for a fast examination. This helpseliminate artifacts due patient motion and reduces radiation exposuretime. In various embodiments, an X-ray system 100 is configured for a 1second to 1.5 second total exposure time for dual-energy densitometryand less than 2 second total exam time. In various embodiments, exposuretimes can be 5, 4.5, 4, 3.5, 3, 2.5, 2, 1.5, 1, and/or 0.5 seconds orless.

In one embodiment, an X-ray system 100 incorporates an imaging detector300 and a light-weight X-ray tube 200 that is encapsulated inlow-density insulating materials, such as silicon rubber, to reduce theweight of the insulation and the structure housing. In variousembodiments, an X-ray system 100 can have any duty cycle 210. In variousembodiments, the duty cycle 210 can be 1/1000, 1/900, 1/800, 1/700,1/600, 1/500, 1/400, 1/300, 1/200, or 1/5 and/or any range therein. Invarious embodiments, the duty cycle 210 can be 1/100, 1/90, 1/80, 1/70,1/60, 1/50, 1/40, 1/30, 1/20, 1/10, 1/5, and/or any range therein. Forexample, in one embodiment, an X-ray system 100 has a duty cycle 210 of1/60. In one embodiment, an X-ray source can generate a maximum of a twosecond of pulsed radiation with duty cycle of 1/60. In other words, the1/60 duty cycle has a pulse then a delay of 120 seconds: the nextsequential pulse occurs after a 120 second delay after first pulse.

In one embodiment, an X-ray system 100 uses a two-exposure techniquethat uses relatively larger imaging field of view and larger digitaldata format than other peripheral DXA systems. In one embodiment, anX-ray system 100 is configured to measure bone densitometry with amethod of quantitative imaging with resolutions of up to (or exceeding)1% precision and accuracy of measurement of bone mass.

In one embodiment, an X-ray system 100 is configured for Dual-energyX-ray absorptiometry (“DXA”) as a way of measuring Bone Mineral Density(“BMD”). In one embodiment, DXA involves two X-ray beams with differingenergy levels that are directed toward a target bone for measurement.After soft tissue absorption is subtracted out of the signal, BMD can bedetermined from the absorption of each beam by bone. In one embodiment,the DXA scan is used to diagnose and follow osteoporosis.

In various embodiments, various techniques of dual-energy imaging anddensitometry can be used. Various methods can be used to produce twodistinct energetic beams. In one embodiment, an X-ray system 100 is adual-energy imaging and densitometry system that uses a passive methodthat employs K-edge filtration to partition the X-ray spectrum into twoenergy regions. In one embodiment, an X-ray system 100 is a dual-energyimaging and densitometry system that uses an active method that makesuse of two peak voltages switching (kVp switching) to alternatelygenerate two energy spectrums. Generally, when using a dual-energymedical imaging system, motion artifacts can cause concern due totemporal interval between two energy exposures. Thus, in one embodiment,an X-ray system 100 is configured with a temporal delay that is kept asshort as possible. In some embodiments, the temporal delay is 2 secondsor less, 1 second or less, 0.5 seconds or less, 0.1 seconds or less, 500ms or less, 250 ms or less, 100 ms or less, 50 ms or less, or 10 ms orless. In certain circumstances, two primary elements that impact thetemporal interval are dual-energy switching and dataacquisition/recording of the first exposure data. In one embodiment,each are synchronized to function simultaneously after the firstradiation exposure.

In various embodiments, an X-ray system 100 can use tube voltageswitching. In one embodiment, dual-energy is produced by two differentHigh Voltages (HV) supplied to an X-ray tube without a filter exchanger.In one embodiment, separation of two distinguished energy spectrum isinteriors. In various embodiments, an X-ray system 100 can use energyfiltration. In one embodiment, energy filtration uses high and energyspectrums that are obtained by placing high and low energy filters at abeam pass in front of a tube outlet window. Two advantages are a) simpleX-ray power supply design; and b) fast switching time, which can belimited to less than 100 ms.

In various embodiments, an X-ray system 100 can use a combination oftube voltage switching with energy filtration. In one embodiment, acombined approach can be technically superior to achieve an optimaldistinguished energy spectrum, good dual-energy separation that resultsin high imaging signal-to-noise ratio (SNR) and low artificial effect ofbeam-hardening. In one embodiment, the near mono-chromatic spectrum ofdual-energy and good energy separation between high and low energies canbe important for improving SNR and reduce beam-hardening of quantitativeimaging. In one embodiment, SNR decreases and the effect ofbeam-hardening increases with increase of body size (thickness andweight), which can result in sacrifices in both precision and accuracyof quantitative measurement. However, the forearm presents one of thesmallest and thinnest parts of human body for bone imaging and/ormeasurement, and certain adverse effects are minimized and can becorrected through post-data algorithms if necessary.

In some circumstances, the data associated with higher resolutionimaging is large. Owing to large imaging data format, flat-paneldetector data acquisition and recording can be time-consuming. A simpleand cost-effective way to improve its efficiency and performance isincorporating detector module 300 and embedded system 150 within theimaging X-ray system 100 device.

In one embodiment, a detector 300 includes a flip-chip bonded detectorchip and integrated electronics chip. Chip level integration can allowfor faster electronic signal conversion and amplification. Eachprocessed image frame can be exported via Giga-Ethernet, camera link, orvia another format or means. In one embodiment, an image frame isreceived and processed by an embedded system chip 150 and stored inadjacent DDR3 SRDRAM. In one embodiment, the estimated processing timeis about ˜60 ms for 48 Mbit of data.

In one embodiment, an X-ray system 100 is configured for dual-energyimaging and densitometry according to an embodiment of the presentinvention. In one embodiment, the X-ray system 100 comprises a filterpositioning mechanism 400 configured for changing position in order toprovide dual-energy imaging and densitometry for the X-ray system 100.In one embodiment, the filter positioning mechanism 400 is a filterexchanger. In one embodiment, the filter positioning mechanism 400 is afilter wheel. In one embodiment, the filter positioning mechanism 400 isa slide. In one embodiment, the filter positioning mechanism 400 is abelt. In one embodiment, the filter positioning mechanism 400 is alinear exchanger. In one embodiment, the filter positioning mechanism400 is a rotational exchanger. In one embodiment, the filter positioningmechanism 400 is a movable system for presenting one, two, three, four,five, six, or more positions on a filter for affecting an X-ray emissionfrom an X-ray tube 200. For example, the filter positioning mechanism400 can comprise one or more filter positioning mechanism positions 410.In various embodiments, the filter positioning mechanism 400 can include1, 2, 3, 4, 5, 6, or more filter positioning mechanism positions 410. Inone embodiment, a filter positioning mechanism position 410 can includea high energy filter 420 configured to allow high energy X-raytransmission through the filter positioning mechanism 400. In oneembodiment, the high energy filter 420 provides a high energy componentfor transmission through the filter positioning mechanism, and limitslow energy transmission. In one embodiment, the high energy filter 420absorbs lower energy. In one embodiment, a filter positioning mechanismposition 410 can include a low energy filter 430 configured to allow lowenergy X-ray transmission through the filter positioning mechanism 400.In one embodiment, the low energy filter 430 provides for lower energytransmission of energy through the filter positioning mechanism. In oneembodiment, the low energy filter 430 provides for second high energytransmission of energy through the filter positioning mechanism. In oneembodiment, a filter positioning mechanism position 410 can include ashutter 440 for blocking X-ray transmission through the filterpositioning mechanism 400. In one embodiment, a filter positioningmechanism position 410 can include a datum indicator 450 to indicate theposition of the filter positioning mechanism 400 in the X-ray system100. In one embodiment, a filter positioning mechanism position 410 caninclude any number of filters, shutters, indicators, or other devices,lenses, objects, interfaces, or other features for modifying thefunction of the X-ray system 100. In one embodiment, a filter exchangeris driven by a high-torque and high speed stepping motor. In oneembodiment, a filter exchanger is configured to switch from one positionto anther in 100 ms or less.

In various embodiments, an X-ray system 100 configured for dual-energyimaging and densitometry. In the embodiments, specific time ranges ortime values can be provided as examples, but can vary accordingly. Inone embodiment, a time scale 170 shows various steps taken by an X-raysystem 100. In one embodiment, a time scale 170 shows various stepstaken by an X-ray system 100 with a filter positioning mechanism 400. Inone embodiment, the time scale 170 provides illustrative timingsequences with a two second interval. In one embodiment, the X-raysystem 100 activates X-ray tube 200, showing the X-ray status 172 (e.g.“on”, “off”, “HV”, “LV”, etc.) during the time scale 170. In someembodiments, illustrated in priority to U.S. Provisional Application No.61/664,066, filed on Jun. 25, 2012, FIGS. 4A-4C illustrate variousactions performed in a time period by various embodiments an X-raysystem. U.S. Provisional Application No. 61/664,066, filed on Jun. 25,2012, is incorporated by reference in its entirety, herein. Further,FIGS. 4A-4C and the related description from U.S. ProvisionalApplication No. 61/664,066 is incorporated by reference herein.

In one embodiment of a constant X-ray tube High Voltage (HV) system, theX-ray status 172 has an X-ray tube 200 that turns on from an offposition, ramping to “on” status between 0 to 0.2 seconds. The X-raystatus 172 remains “on” until the 1.6 second mark, at which the powerramps downward to the off position during duty cycle period, and remainsoff until the 2.0 second mark. In various embodiments, the switching canbe a step instead of a ramp, or some other profile. In one embodiment, afilter positioning mechanism position 174 is a filter exchangerposition. In one embodiment, a filter positioning mechanism position 174is a filter wheel position.

In one embodiment a constant X-ray tube High Voltage (HV) system has theX-ray system 100 activate the filter positioning mechanism 400, with thefilter positioning mechanism position 174 during the time scale 170. Inone embodiment, the filter positioning mechanism position 174 is at theshutter 440 at time zero, transitions between 0.2 to 0.4 seconds to afilter positioning mechanism position 174 for the high energy filter 420between 0.4 to 0.9 seconds, transitions between 0.9 to 1.1 seconds to afilter positioning mechanism position 174 for the low energy filter 430between 1.1 to 1.6 seconds, then returns to a shutter 440 positionbetween 1.8 to 2.0 seconds on the time scale 170. In one embodiment, thehigh energy filter 420 is configured for transmission of a first highenergy level. In one embodiment, the low energy filter 430 is configuredfor transmission of a second high energy level, wherein the second highenergy level is lower than a first high energy level.

In one embodiment, a constant X-ray tube High Voltage (HV) system hasthe X-ray system 100 activate the data acquisition status 176 to an “on”position to acquire data during the high energy filter 420 position withan exposure time of 0.4-0.9 seconds. In one embodiment, the dataacquisition status 176 switches to a “Transfer & Recording” mode at 0.9to 1.1 seconds. The X-ray system 100 activates the data acquisitionstatus 176 to an “on” position to acquire data during the low energyfilter 430 position with an exposure time of 0.3-0.5 seconds. In oneembodiment, the data acquisition status 176 switches to a “Transfer &Recording” mode at 1.6 to 2.0 seconds. In various embodiments, a datatransfer and/or recording means image frame can be moved from a detectormodule to the SoC through Gig Ethernet and/or Camera Link and to besaved in DDR3 memory temporally. In one embodiment, data and/or an imagecan be saved permanently.

In one embodiment, the X-ray system 100 activates the data recordingstatus 178 to an “on” position to transfer the acquired data to datastorage at roughly the 0.9 to 1.1 second mark, after the dataacquisition is off. The data recording status 178 returns to an “on”position to transfer the acquired data to data storage at roughly the1.6 to 1.8 second mark, after the data acquisition is off. In oneembodiment, the data recording or transfer to storage can occur whilethe data acquisition is taking place. In one embodiment, the datarecording or transfer to storage can occur after the data acquisitionhas taken place. In some embodiments, the switching can be a stepinstead of a ramp, or some other profile.

In one embodiment, a switchable X-ray tube HV without a filterexchanger, has an X-ray system 100 that activates the data acquisitionstatus 176 to an “on” position to acquire data during the high energyfilter 420 position with an exposure time of 0.4-0.9 seconds. In oneembodiment, the data acquisition status 176 switches to a “Transfer &Recording” mode at 0.9 to 1.1 seconds. The X-ray system 100 activatesthe data acquisition status 176 to an “on” position to acquire dataduring the low energy filter 430 position with an exposure time of0.3-0.5 seconds. In one embodiment, the data acquisition status 176switches to a “Transfer & Recording” mode at 1.6 to 2.0 seconds. Invarious embodiments, a data transfer and/or recording means image framecan be moved from a detector module to the SoC through Gig Ethernetand/or Camera Link and to be saved in DDR3 memory temporally. In oneembodiment, data and/or an image can be saved permanently. In someembodiments, the switching can be a step instead of a ramp, or someother profile.

In one embodiment, a combination of switchable HV with a filterexchanger has an X-ray status 172 with the X-ray tube 200 turning onfrom a first HV position, ramping to the first HV position statusbetween 0 to 0.2 seconds. In one embodiment, the X-ray status 172remains at the first HV position until the 0.9 second mark, at which thepower ramps downward to a second HV position by the 1.1 second mark, andremains at the second HV position until the 1.6 second mark. In oneembodiment, the X-ray status 172 remains at the first HV position untilthe 0.9 second mark, at which the power ramps downward to a LV or lowervoltage position by the 1.1 second mark, and remains at the LV positionuntil the 1.6 second mark. In some embodiments, the switching can be astep instead of a ramp, or some other profile.

In one embodiment, a combination of switchable HV with a filterexchanger has the X-ray system 100 activating the filter positioningmechanism 400, showing the filter positioning mechanism position 174during the time scale 170. In one embodiment, the filter positioningmechanism position 174 is at the shutter 440 at time zero, transitionsbetween 0.2 to 0.4 seconds to a filter positioning mechanism position174 for the high energy filter 420 between 0.4 to 0.9 seconds,transitions between 0.9 to 1.1 seconds to a filter positioning mechanismposition 174 for the low energy filter 430 between 1.1 to 1.6 seconds,then returns to a shutter 440 position between 1.8 to 2.0 seconds on thetime scale 170.

In one embodiment, a combination of switchable HV with a filterexchanger has the X-ray system 100 activate the data acquisition status176 to an “on” position to acquire data during the high energy filter420 position with an exposure time of 0.4-0.9 seconds. In oneembodiment, the data acquisition status 176 switches to a “Transfer &Recording” mode at 0.9 to 1.1 seconds. The X-ray system 100 activatesthe data acquisition status 176 to an “on” position to acquire dataduring the low energy filter 430 position with an exposure time of0.3-0.5 seconds. In one embodiment, the data acquisition status 176switches to a “Transfer & Recording” mode at 1.6 to 2.0 seconds. Invarious embodiments, a data transfer and/or recording means image framecan be moved from a detector module to the SoC through Gig Ethernetand/or Camera Link and to be saved in DDR3 memory temporally. In oneembodiment, storage is permanent.

FIGS. 4A-4C illustrate various actions performed in a time period byvarious embodiments of an X-ray system 100 configured for dual-energyimaging and densitometry. In the illustrated embodiments, specific timeranges or time values are provided as examples, but can varyaccordingly. In one embodiment, a time scale 170 shows various stepstaken by an X-ray system 100. In one embodiment, a time scale 170 showsvarious steps taken by an X-ray system 100 with a filter positioningmechanism 400. In one embodiment, the time scale 170 providesillustrative timing sequences with a two second interval. In oneembodiment, the X-ray system 100 activates X-ray tube 200, showing theX-ray status 172 (e.g. “on”, “off”, “HV”, “LV”, etc.) during the timescale 170.

In one embodiment, a filter positioning mechanism position 174 is afilter exchanger position. In one embodiment, a filter positioningmechanism position 174 is a filter wheel position.

In one embodiment shown at FIG. 4A (constant X-ray tube High Voltage(HV)), the X-ray status 172 shows the X-ray tube 200 turns on from anoff position, ramping to “on” status between 0 to 0.8 seconds. The X-raystatus 172 remains “on” until the 2.8 second mark. The status can thendrop to an off status. In various embodiments, the switching can be astep instead of a ramp, or some other profile.

In one embodiment shown at FIG. 4A (constant X-ray tube High Voltage(HV)), the X-ray system 100 activates the filter positioning mechanism400, showing the filter positioning mechanism position 174 (or filterexchanger position) during the time scale 170. In one embodiment, thefilter positioning mechanism position 174 is at the shutter 440 at timezero, transitions between 0.8 to 1.0 seconds to a filter positioningmechanism position 174 for the high energy filter 420 between 1.0 to 1.9seconds, transitions between 1.9 to 2.1 seconds to a filter positioningmechanism position 174 for the low energy filter 430 between 2.1 to 2.6seconds, then returns to a shutter 440 position between 2.6 to 2.8seconds on the time scale 170. In one embodiment, the high energy filter420 is configured for transmission of a first high energy level. In oneembodiment, the low energy filter 430 is configured for transmission ofa second high energy level, wherein the second high energy level islower than a first high energy level.

In one embodiment, a data acquisition status 176 is a camera status 176.

In one embodiment shown at FIG. 4A (constant X-ray tube High Voltage(HV)), the X-ray system 100 activates the data acquisition status 176 toan “on” position to acquire data during the high energy filter 420position with an exposure time of 0.4-0.9 seconds. In one embodiment,the data acquisition status 176 switches to a “Transfer & Recording”mode at 1.9 to 2.1 seconds. The X-ray system 100 activates the dataacquisition status 176 to an “on” position to acquire data during thelow energy filter 430 position with an exposure time of 0.1-0.5 seconds.In one embodiment, the data acquisition status 176 switches to a“Transfer & Recording” mode at 2.6 to 2.8 seconds. In variousembodiments, a data transfer and/or recording means image frame can bemoved from a detector module to the SoC through Gig Ethernet and/orCamera Link and to be saved in DDR3 memory temporally. In oneembodiment, data and/or an image can be saved permanently.

In one embodiment shown at FIG. 4B (switchable X-ray tube HV without afilter exchanger), the X-ray status 172 shows the X-ray tube 200 turnson from a first HV position, ramping to the first HV position statusbetween 0 to 0.8 seconds. In one embodiment, the X-ray status 172remains at the first HV position until the 1.9 second mark, at which thepower ramps downward to a second HV position by the 2.1 second mark, andremains at the second HV position until the 2.8 second mark. In oneembodiment, the X-ray status 172 remains at the first HV position untilthe 1.9 second mark, at which the power ramps downward to a LV or lowervoltage position by the 2.1 second mark, and remains at the LV positionuntil the 2.8 second mark. In other embodiments, the switching can be astep instead of a ramp, or some other profile.

In one embodiment shown at FIG. 4B (switchable X-ray tube HV without afilter exchanger), the X-ray system 100 activates the data acquisitionstatus 176 to an “on” position to acquire data during the high energyfilter 420 position with an exposure time of 0.4-0.9 seconds. In oneembodiment, the data acquisition status 176 switches to a “Transfer &Recording” mode at 1.9 to 2.1 seconds. The X-ray system 100 activatesthe data acquisition status 176 to an “on” position to acquire dataduring the low energy filter 430 position with an exposure time of0.1-0.5 seconds. In one embodiment, the data acquisition status 176switches to a “Transfer & Recording” mode at 2.6 to 2.8 seconds. Invarious embodiments, a data transfer and/or recording means image framecan be moved from a detector module to the SoC through Gig Ethernetand/or Camera Link and to be saved in DDR3 memory temporally. In oneembodiment, data and/or an image can be saved permanently. In someembodiments, the switching can be a step instead of a ramp, or someother profile.

In one embodiment shown at FIG. 4C (combination of switchable HV with afilter exchanger), the X-ray status 172 shows the X-ray tube 200 turnson from a first HV position, ramping to the first HV position statusbetween 0 to 0.8 seconds. In one embodiment, the X-ray status 172remains at the first HV position until the 1.9 second mark, at which thepower ramps downward to a second HV position by the 2.1 second mark, andremains at the second HV position until the 2.8 second mark. In oneembodiment, the X-ray status 172 remains at the first HV position untilthe 1.9 second mark, at which the power ramps downward to a LV or lowervoltage position by the 2.1 second mark, and remains at the LV positionuntil the 2.8 second mark. In some embodiments, the switching can be astep instead of a ramp, or some other profile.

In one embodiment shown at FIG. 4C (combination of switchable HV with afilter exchanger), the X-ray system 100 activates the filter positioningmechanism 400, showing the filter positioning mechanism position 174during the time scale 170. In one embodiment, the filter positioningmechanism position 174 is at the shutter 440 at time zero, transitionsbetween 0.8 to 1.0 seconds to a filter positioning mechanism position174 for the high energy filter 420 between 1.0 to 1.9 seconds,transitions between 1.9 to 2.1 seconds to a filter positioning mechanismposition 174 for the low energy filter 430 between 2.1 to 2.6 seconds,then returns to a shutter 440 position between 2.6 to 2.8 seconds on thetime scale 170.

In one embodiment shown at FIG. 4C (combination of switchable HV with afilter exchanger), the X-ray system 100 activates the data acquisitionstatus 176 to an “on” position to acquire data during the high energyfilter 420 position with an exposure time of 0.4-0.9 seconds. In oneembodiment, the data acquisition status 176 switches to a “Transfer &Recording” mode at 1.9 to 2.1 seconds. The X-ray system 100 activatesthe data acquisition status 176 to an “on” position to acquire dataduring the low energy filter 430 position with an exposure time of0.1-0.5 seconds. In one embodiment, the data acquisition status 176switches to a “Transfer & Recording” mode at 2.6 to 2.8 seconds. Invarious embodiments, a data transfer and/or recording means image framecan be moved from a detector module to the SoC through Gig Ethernetand/or Camera Link and to be saved in DDR3 memory temporally. In oneembodiment, storage is permanent.

FIGS. 4D-4E illustrate various actions performed in a time period byvarious embodiments of an X-ray system 100 configured for single-energyradiography for imaging and densitometry. In the illustratedembodiments, specific time ranges or time values are provided asexamples, but can vary accordingly. In one embodiment, a time scale 170shows various steps taken by an X-ray system 100. In one embodiment, atime scale 170 shows various steps taken by an X-ray system 100 with afilter positioning mechanism 400. In one embodiment, the time scale 170provides illustrative timing sequences. In one embodiment, the X-raysystem 100 activates X-ray monoblock 200, showing the X-ray status 172(e.g. “on”, “off”, “HV”, “LV”, etc.) during the time scale 170, with afilter wheel position 174 and a camera status 176.

In one embodiment, such as shown at FIG. 10, an optional anti-scatteringgrid 122 can be positioned on top of a detector panel 300. In oneembodiment, anti-scattering grid 122 is used in single energy highresolution radiography. In one embodiment, anti-scattering grid 122 isnot used during dual-energy operation (i.e. dual-energy bonedensitometry).

In one embodiment shown at FIG. 4D (an X-ray system with a single-energyradiographic operation, single exposure), the X-ray status 172 shows theX-ray monoblock 200 turns on from an off position, ramping to “on”status between 0 to 0.8 seconds. The X-ray status 172 remains “on” untilthe 1.5 second mark, at which the power ramps downward to the offposition by the 1.5 second mark. In various embodiments, the switchingcan be a step instead of a ramp, or some other profile.

In one embodiment shown at FIG. 4D (X-ray system with a single-energyradiographic operation, single exposure), the X-ray system 100 activatesthe filter positioning mechanism 400, showing the filter wheel position174 during the time scale 170. In one embodiment, the filter wheelposition 174 is at the shutter 440 at time zero, transitions between 0.8to 1.0 seconds to a filter wheel position 174 for the desirable energyfilter 420 between 1.0 to 1.5 seconds, then transitions to a filterwheel position 174 for the low energy filter. In one embodiment, thehigh energy filter 420 is configured for transmission of a first highenergy level.

In one embodiment shown at FIG. 4D (X-ray system with a single-energyradiographic operation, single exposure), the X-ray system 100 activatesthe camera status 176 to an “on” position to acquire data during thehigh energy filter 420 position with an exposure time of 5-100 ms. Inone embodiment, x-ray pulse is activated for 5 ms. In one embodiment,x-ray pulse is activated for 10 ms. In one embodiment, x-ray pulse isactivated for 20 ms. In one embodiment, x-ray pulse is activated for 30ms. In one embodiment, x-ray pulse is activated for 40 ms. In oneembodiment, x-ray pulse is activated for 50 ms. In one embodiment, x-raypulse is activated for 100 ms. In one embodiment, the camera status 176switches to a “Transfer & Recording” mode at 0.05-1.0 seconds. The X-raysystem 100 activates the camera status 176 to an “on” position toacquire data during the low energy filter 430 position. In oneembodiment, the camera status 176 switches to a “Transfer & Storing”mode. In various embodiments, a data transfer and/or storing means imageframe can be moved from a detector module to the SoC through GigEthernet and/or Camera Link and to be saved in DDR3 memory temporally.In one embodiment, data and/or an image can be saved permanently.

In one embodiment, a single energy radiography, continued pulse exposuresystem can operate by switching the filter wheel to a desirable positionfrom a shutter position. The X-ray can be set to a desirable highvoltage level. In one embodiment, a detector exposure is active for0.05-0.1 seconds. The data can be saved and the X-ray switched off. Invarious embodiments, the system can perform a duty cycle with a ratio ofexposure duration and down-time duration, such as 1/2, 1/5, 1/10, 1/20,1/30, or 1/60, or otherwise. In various embodiments, the X-ray voltagelevel, detector exposure, and saving data and turning the X-ray off canbe repeated. In various embodiments, the process continues as long asneeded.

In one embodiment shown at FIG. 4E (single energy radiography, continuedpulse exposure), the X-ray status 172 shows the X-ray monoblock 200turns on for a step-wise “on” position, which can be repeated.

In one embodiment shown at FIG. 4E (single energy radiography, continuedpulse exposure), the X-ray system 100 activates the camera status 176 toan “on” position to acquire data during the X-ray status 172 “on”position.

In one embodiment, a flow chart of various steps performed by an X-raysystem according to an embodiment of the present invention are shown atFIG. 4F.

FIGS. 5A-5B illustrate a filter positioning mechanism 400 according toan embodiment of the present invention. In one embodiment, a filterpositioning mechanism 400 has filter positioning mechanism positions 410that can include a high energy filter 420, and a low energy filter 430.In one embodiment, a filter positioning mechanism 400 has filterpositioning mechanism positions 410 that can include a high energyfilter 420, a low energy filter 430, and a shutter 440. In oneembodiment, a filter positioning mechanism 400 has filter positioningmechanism positions 410 that can include a high energy filter 420, a lowenergy filter 430, a shutter 440 and a datum indicator 450. In oneembodiment, the filter positioning mechanism 400 is positioned with amotor. In one embodiment, the filter positioning mechanism 400 isrotatably or linearly positioned with a stepper motor 460. In oneembodiment, a motor sensor 462 detects the position of the motor 460. Inone embodiment, a filter positioning mechanism sensor 470 detects theposition of the filter positioning mechanism 400. In one embodiment, thefilter positioning mechanism sensor 470 interacts with a datum indicator450 on the filter positioning mechanism 400 to register a position. Inone embodiment, the datum indicator 450 is a hold in the filterpositioning mechanism and the filter positioning mechanism sensor 470comprises an emitter/detector sensor pair (such as an LED and a photodiode) for sensing when the datum indicator 450 passes over or betweenthe filter positioning mechanism sensor 470. In one embodiment, a beamcollimator 480 made of lead is used to block unused x-rays that fallsoutside the field of view of image receptor.

FIG. 6 illustrates the filter positioning mechanism 400 with an X-raytube 200 according to FIG. 5A, according to an embodiment of an X-raysystem 100. In one embodiment, the X-ray tube 200 emits an X-ray beam202 toward an imaging detector 300. In one embodiment, the X-ray beam202 is a cone beam.

FIG. 7 illustrates an X-ray system 100 according to an embodiment of thepresent invention. The X-ray system 100 comprises a housing 120, aprinted circuit board embedded system 150, an X-ray tube 200 configuredto emit a cone X-ray beam 202, a LCD/touch screen interface 140, and anX-ray detector 300. The housing 120 includes a fan, power plug outlet,and any number of connectors 130. The X-ray system 100 is configured forplacement of a bone in a patient over the detector 300 and under theX-ray monoblock 200. For example, in one embodiment, a forearm 500 (notillustrated) is placed in the X-ray system 100 for dual-energy imagingand densitometry. In one embodiment, an X-ray system 100 is configuredfor measurement of the ultra-distal (“UD”) radius and/or at the 33%radius for a dominate arm, a non-dominate arm, or both. FIG. 8A is aradiographic image of a forearm 500 by an X-ray system 100 according toan embodiment of the present invention. FIG. 8B is a bone density imageof the forearm 500 by the X-ray system 100 according to FIG. 8A.

FIGS. 9A-9C illustrate an X-ray system 100 according to the embodimentin FIG. 7 with a filter positioning mechanism 400 according to anembodiment of the present invention. In one embodiment, the X-ray system100 The X-ray system 100 comprises a housing 120, a printed circuitboard embedded system 150, an X-ray tube 200 configured to emit a coneX-ray beam 202, a LCD/touch screen interface 140, an X-ray detector 300,a filter positioning mechanism 400 and a motor 460. FIGS. 10-13illustrate the embodiment of the X-ray system 100 of FIGS. 9A-9C.

In one embodiment of the present invention, a portable imaging and bonedensity monitoring X-ray system 100 is an ultra-compact and light-weightdual-energy imaging device is configured to image a bone site andestimate bone density using an X-ray source with a high resolution/speedimaging detector. In various embodiments, the bone site can be aperipheral bone site, such as (but not limited to) an arm, a fore arm, ahand, a wrist, a finger, a leg, a shin, an ankle, a heel, a foot, a toe,or other body site.

In one embodiment, an X-ray system 100 includes a flat-panel detector300, an X-ray source 200 with system integration using embedded system150 design (including incorporating a microprocessor, touch-screen 140and USB connection 132 and /or a wireless interfaces 134. In oneembodiment, an X-ray system 100 includes a single pulsed X-ray source(for less than 2 seconds) to acquire dual-energy imaging data. The flatpanel detector 300 module is integrated with internal high-speedelectronics and various connectors 130, such as (but not limited to)Ethernet and/or camera links. In one embodiment, an X-ray system 100includes “System-on-chip” (SoC)/“System-on-board” (SoB 152) technologyto integrate system (dual-energy exposures, motor control, high-speeddata transfer and storage, etc.) In one embodiment, an X-ray system 100is similar to a pDXA device but also can be served as high resolutionimaging device or small field radiography. In one embodiment, an X-raysystem 100 uses dual-energy methods to measure bone density at forearm,from Ultra-distal (UD) to 33% of forearm. It can take radiographicimaging of a forearm or a hand or a foot (with the option of single ordual-energy imaging). It can take radiographic imaging of a small animal(with the option of single or dual-energy imaging).

In one embodiment, an X-ray system 100 includes a low-weight X-raymonoblock 200 and pulsed X-ray radiation emitted in an X-ray beam 202.In one embodiment, the X-ray tube 200 source may be a monoblock withoutadditional cooling utility. In one embodiment, the X-ray tube 200 sourcehas a fixed tube voltage in the range of 70-80 kV and fixed tube currentin the range of 2-5 mA. In one embodiment, the X-ray tube 200 source hasa variable/adjustable tube voltage from 40 to 80 kV and fixed tubecurrent in the range of 2-5 mA. In one embodiment, the X-ray tube 200source has a pulsed width with a 2 second (max) and a duty cycle of1/60. In one embodiment, the X-ray tube 200 source has a voltagerise-time of less than 200 ms from 10% to 90% of rated voltage. In oneembodiment, the X-ray tube 200 source has a focal spot size: less than0.4 mm. In one embodiment, the X-ray tube 200 source emits a beam 202with cone beam geometry. In one embodiment, an X-ray system 100 is lightweight, with a total weight for the X-ray monoblock 200 and the controlboard of less than 5 pounds.

In one embodiment, an X-ray system 100 includes a high resolution flatpanel X-ray detector module 300. In one embodiment, the flat paneldetector 300 has a pixel size of 75-150 micron pitch to pitch. Invarious embodiments, the active area can be approximately 13×13 cm or15×12 cm. In various embodiments, the active area is large enough toimage a forearm from UD to 33% of radius. In one embodiment, the numbersof pixels is approximately 1.5 million pixels for 140 micron and ˜3million pixels for 75 micron. In one embodiment, the digital output is14 or 16 bit/pixel. In one embodiment, the image data output is 16bit/pixel×3 million pixels=48 Mbits. In one embodiment, flat paneldetector module has a Giga-bit Ethernet for data transmission. Forinstance, a transmission time of 80% of one set of 48 Mbits image is 60ms (=48/0.8). In one embodiment, flat panel detector module provides aCamera Link for data transmission. In one embodiment, the X-rayconversion can use a CsI scintillator, a Gadox scintillator, or otherscintillator.

In one embodiment, an X-ray system 100 includes an embedded system 150using a System-on-Board (SoB 152) 152 design powered by System-on-Chip(SoC) technology. In one embodiment, an X-ray system 100 uses a SoB 152with a custom-designed PCB (Printed Circuit Board) powered bySystem-on-Chip (SoC) technology. In one embodiment, the PCB is a SoB152.

In one embodiment, an X-ray system 100 includes a SoB 152 that containsa PBGA IC (SoC or System-on-Chip) that includes an internalmicroprocessor (for example, operating a 500 MHz, 700 MHz, or otherfrequencies) for system control and operating system (OS) support. Inone embodiment, an X-ray system 100 includes a SoB 152 with low powerconsumption, such as at 7 mW standby power and 700 mW active power. Inone embodiment, an X-ray system 100 includes a SoB 152 with integrated3-D graphics and a touch screen controller 140. In one embodiment, anX-ray system 100 includes a SoB 152 with fast network connectivity,which can include a Giga-bit Ethernet controller, DDR3 SDRAM interfaceand/or a USB controller. In one embodiment, an X-ray system 100 includesa SoB 152 with on-chip peripherals, such as for connection to sensors,actuators, devices and cost optimization. In one embodiment, an X-raysystem 100 includes a SoB 152 with a PCB size (5″×6″) capable ofhigh-speed/high band-width PCB layout to accommodate Giga-bit Ethernetand/or DDR3 data rates. In one embodiment, an X-ray system 100 includesa SoB 152 can have DDR3 SDRAM IC (adjacent to SoC, allowing for data tobe transferred and stored quickly (for instance to acquire and save oneset of image frame in less than 100 milliseconds). In one embodiment, anX-ray system 100 includes a SoB 152 with one or more, or any combinationof, a flash memory integrated circuit, a stepping motormicro-controller, stepping motor positioning circuitry/IC, power supplyconverter/regulator, and/or a Wi-Fi/blue-tooth module. Note: DDR3 standsfor (Double Data Rate, type 3). Note: SDRAM stands for (SynchronousDynamic Random Access Memory).

In one embodiment, an X-ray system 100 is configured for dual-energyfiltration. In one embodiment, the X-ray system 100 has a filterexchanger assembly (or filter positioning mechanism 400) implemented bya stepping motor and positioning mechanism. In one embodiment, thefilter positioning mechanism 400 comprises one position for a highenergy filter 420 that can provide a high energy component above 40-50kV. In one embodiment, the high energy filter 420 includes Copper(Cu)+Tin (Sn) and/or Copper (Cu)+Rhodium (Rh).

In one embodiment, the filter positioning mechanism 400 comprises oneposition for a low energy filter 430 that can provide filtration of highenergy component below 40-50 kV. In one embodiment, the low energyfilter 430 includes Aluminum (Al)+one type of material having one K-edgeabsorption around 40 kV. In various embodiments, the K-edge materialscan be one or more of Cerium (Ce, K-edged at 40 kV), Samarium (Sm,K-edged at 46.8 kV), Gadolinium (Gd, K-edged at 50.2 kV), Barium (Ba,K-edged at 37.45 kV).

In one embodiment, the filter positioning mechanism 400 comprises oneposition for a shutter 440 (permanently closed) position to blockradiation for safety, non-exam time, etc. In any embodiment, the filterpositioning mechanism 400 can add or remove one or more positions and/orfilters, whenever it is needed.

In one embodiment, the filter positioning mechanism 400 is mounted on ahigh-torque stepping motor 460 that rotates the filter positioningmechanism 400 is instructed to by the system. In one embodiment, ahigh-torque stepping motor allows for speedy exchange of filters orpositions. In one embodiment, the estimated switching time is about˜50-100 ms from one position to another.

In one embodiment, an X-ray system 100 accounts for potential scatteringaffects that may impact negatively to imaging quality. Scatteringincreases with increase of body size (thickness and weight). Howeverforearm presents smallest and thinnest part of human body and scatteringcan be estimated through post-data algorithm if necessary.

In relation to FIG. 4F, in various embodiments, the operation procedureof various embodiments of an X-ray system 100 for dual energy bonedensitometry includes any one or more of the following steps, in anyorder:

a) Turn on the power and warm up the machine.

b) Built-In-Test (BIT).

c) Measure the length of patient forearm (for determination of 33%radius BMD).

d) Input the patient's information from either touch-screen or externalcomputer through wire (USB) or wireless (Wi-Fi or Blue-tooth).

e) Position the patient forearm.

f) Run patient exam. In accord with the example embodiment of FIG.4A-4C), the X-ray tube power is turned on. 0.8 s delay (includingfilament preheat and rise time of tube voltage). Positioning mechanismstays in a block shuttered position to avoid radiation exposure. ThePositioning mechanism switches to a low energy position. 0.2 seconddelay. Low energy data acquisition by detector is turned on. Exposuretime 0.5-0.9 second. SNR can be optimized by adjusting exposure timeaccording to the thickness of patient forearm. Low energy datatransferring and recording (low energy image to be transferred and savedin DDR3 SDRAM temporally)-total time ˜0.2 seconds. Simultaneously,positioning mechanism switches to high energy position (0.2 seconds).High energy data acquisition by detector is on. Exposure time can be0.3-0.5 seconds. SNR can be optimized by adjusting exposure timeaccording to the thickness of patient forearm. High energy datatransferring and recording (high energy image to be transferred andsaved in DDR3 SDRAM temporally-total time ˜0.2 seconds. Simultaneously,positioning mechanism switches back to the block position (0.2 seconds)and X-ray tube power off (0.2 seconds).

g) Data processing and display.

h) Data stored in flash memory for permanent storage.

i) User Option: transfer data to external computer/storage by wire (USB)or wireless (Wi-Fi or Blue-tooth) if needed.

j) Next exam: system will be locked “power-off” until delay of 120seconds from previous exam.

In relation to FIGS. 4A-4F, in various embodiments, the operationprocedure of various embodiments of an X-ray system 100 for singleenergy radiography can include any one or more of the following steps,in any order:

a) Turn on the power and warm up the machine.

b) Built-In-Test (BIT).

c) Input the patient's information from either touch-screen or externalcomputer through wire (USB) or wireless (Wi-Fi or Blue-tooth).

d) Position the patient forearm or hand.

e) Run patient exam. The X-ray tube power is turned on. 0.8 second delay(including filament preheat and rise time of tube voltage). Positioningmechanism stays in a block/shuttered position to avoid radiationexposure. Positioning mechanism switches to low energy position or highenergy position. 0.2 s delay. Data acquisition by detector is on.Exposure time 0.4-0.9 seconds. SNR can be optimized by adjustingexposure time according to the thickness of patient forearm or hand.Imaging data to be transferred and saved in DDR3 SDRAM temporally)-totaltime ˜0.2 ms. Simultaneously, positioning mechanism switches back to theblock position (0.2 s) and X-ray tube power off (0.2 s).

f) Data processing and display.

g) Data stored in flash memory for permanent storage.

h) User option: transfer data to external computer/storage by wire (USB)or wireless (Wi-Fi or Blue-tooth) if needed.

i) Next exam: system will be locked “power-off” until delay fromprevious exam. Duration of delay depends on the exposure time accordingto the rule of 1/60 duty cycle.

Some embodiments and the examples described herein are examples and notintended to be limiting in describing the full scope of compositions andmethods of these invention. Equivalent changes, modifications andvariations of some embodiments, materials, compositions and methods canbe made within the scope of the present invention, with substantiallysimilar results.

What is claimed is:
 1. A portable, dual-energy radiographic x-rayimaging and bone density measuring system, comprising: an X-ray sourceconfigured to emit an X-ray beam through a filter positioning mechanism,the filter positioning mechanism comprising a high energy filter, a lowenergy filter, and a shutter configured to block transmission of theX-ray beam; an X-ray imaging detector; a housing positioning the X-raysource at a distance from the X-ray beam detector, wherein the housingis configured for positioning a forearm between the X-ray source and theX-ray beam detector; an embedded system configured to activate the X-raysource and to control the position of the filter positioning mechanismand imaging data acquisition.
 2. The system of claim 1, wherein theX-ray source is active for at most 2 seconds per exposure.
 3. The systemof claim 1, wherein the high energy filter provides a high energycomponent above 40-50 kV for transmission through the filter positioningmechanism.
 4. The system of claim 1, wherein the high energy filtercomprises Copper and at least one of the group consisting of Tin andRhodium.
 5. The system of claim 1, wherein the low energy filter limitstransmission of energy below 40-50 kV through the filter positioningmechanism.
 6. The system of claim 1, wherein the low energy filtercomprises Aluminum and at least one type of material having a K-edgeabsorption at least 40 kV.
 7. The system of claim 1, wherein the lowenergy filter comprises at least one type of material having a K-edgeabsorption of at least 40 kV is selected from the group consisting ofCerium, Samarium, Gadolinium, and Barium.
 8. The system of claim 1,wherein the filter positioning mechanism is actuated by a stepper motorin electric communication with the embedded system.
 9. The system ofclaim 8, wherein the filter positioning mechanism is a filter exchangerconfigured to be rotatably or linearly actuated by the stepper motor.10. The system of claim 9, wherein the stepper motor is a high torqueand high speed design that enables to switch one position to another in100 ms or less.
 11. The system of claim 1, wherein the embedded systemprovides high-speed/high bandwidth data transmission configured fortransmission of imaging data in less than 100 ms.
 12. The system ofclaim 1, wherein the X-ray imaging detector transmits image data throughany one of the group consisting of a Gig-Ethernet and a camera link. 13.The system of claim 1, wherein the embedded chip system operates theX-ray source at a duty cycle of approximately 1/60, for a one secondactive pulsed radiation to sixty second inactive period.
 14. The systemof claim 1, wherein the embedded chip system operates the X-ray sourceat a duty cycle for a two second active pulsed radiation to one hundredtwenty second inactive period.
 15. The system of claim 1, wherein theembedded comprises an operating system configured to process data,control a LCD/touchscreen, manage a power supply, and control acommunication from the group consisting of a USB communication and awireless communication.
 16. The system of claim 1, configured as abattery powered device.
 17. A method for measuring peripheral bonedensity, comprising: positioning a forearm of a patient between an X-raysource and a beam detector in an X-ray system, the X-ray sourceconfigured to emit an X-ray beam through a filter positioning mechanism,the filter positioning mechanism comprising a first energy filter, asecond energy filter, and a shutter configured to block transmission ofthe X-ray beam; activating an embedded chip in said X-ray system, theembedded chip configured to activate the X-ray source and to control theposition of the filter positioning mechanism, wherein said activatingthe embedded chip comprises: activating the X-ray source for two secondsor less; moving the filter positioning mechanism from a shutteredposition to a first energy position with said first energy filter;acquiring first energy data; moving the filter positioning mechanismfrom the first energy position to a second energy position with saidsecond energy filter; and acquiring second energy data.
 18. A portable,single-energy radiographic x-ray system, comprising: an X-ray monoblockconfigured to emit an X-ray beam through a filter positioning mechanism,the filter positioning mechanism comprising a high energy filter, a lowenergy filter, and a shutter configured to block transmission of theX-ray beam; an X-ray imaging detector; an anti-scattering grid betweenthe X-ray monoblock and the X-ray imaging detector; a housingpositioning the X-ray source at a distance from the X-ray beam detector,wherein the housing is configured for positioning a portion of a bodybetween the X-ray source and the X-ray beam detector; an embedded systemconfigured to activate the X-ray source and to control the position ofthe filter positioning mechanism and imaging data acquisition.
 19. Thesystem of claim 18, configured for single exposure.
 20. The system ofclaim 18, configured for continued pulse exposure.
 21. The system ofclaim 18, configured as a battery powered device.